BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1850571 · Received October 1, 2010

    Report

    Report Number
    3005075853-2010-05651
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN UNKNOWN PROCEDURE, THE PATIENT GOT A FEVER OF OVER 40 DEGREES (104 DEGREES FAHRENHEIT) THE NEXT DAY OF THE SURGERY. IT WAS FOUND THAT THE MAJOR LEAK OCCURRED FROM THE ANASTOMOSIS SITE. THE PATIENT WAS RE-OPERATED TO CREATE THE ARTIFICIAL ANUS. THE CUSTOMER DISPOSED OF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TC5K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R